PMID- 31807039
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231019
IS  - 1178-6981 (Print)
IS  - 1178-6981 (Electronic)
IS  - 1178-6981 (Linking)
VI  - 11
DP  - 2019
TI  - Budget Impact Of Including Avelumab As A Second-Line Treatment For Locally 
      Advanced Or Metastatic Urothelial Cancer In The United States: Commercial And 
      Medicare Payer Perspectives.
PG  - 659-672
LID - 10.2147/CEOR.S215069 [doi]
AB  - OBJECTIVE: To estimate the budget impact of introducing avelumab as a second-line 
      (2L) treatment option for patients with locally advanced or metastatic urothelial 
      cancer (mUC) from the perspective of a US third-party payer (commercial and 
      Medicare). METHODS: A budget impact model (BIM) with a three-year time horizon 
      was developed for avelumab. Efficacy and safety data were sourced from published 
      literature and US package inserts. The analysis was conducted in collaboration 
      with a specialist oncologist who validated clinical assumptions. Costs were based 
      on the number of eligible patients, time-to-treatment failure, overall survival, 
      adverse events (AEs), and projected market shares of various treatments. RESULTS: 
      In a hypothetical commercial health plan of 30,000,000 members, 884 patients were 
      estimated to be eligible for 2L treatment over a three-year time period. Without 
      avelumab, the total cost for treating patients with mUC was estimated to be 
      US$70,268,035. The introduction of avelumab increased total costs by $73,438 
      (0.10% increase). In a hypothetical Medicare health plan of 30,000,000 
      beneficiaries, a total of 4,705 patients were estimated to be eligible for 2L 
      treatment. Without avelumab, the total cost for treating patients with mUC was 
      estimated to be $292,923,098 from a Medicare perspective; however, with avelumab, 
      there was an increase of $719,324 (0.25% increase) in total costs. Results of the 
      sensitivity analyses demonstrated a cost-neutral impact across all tested 
      scenarios from both perspectives. CONCLUSION: The BIM estimated that avelumab 
      would have a cost-neutral impact within a US commercial and a Medicare health 
      plan. Overall, avelumab can be an affordable and valuable treatment option for 
      patients with locally advanced or mUC in the 2L setting. These findings 
      demonstrate a consistently favorable budget impact in both populations. Further 
      studies should be conducted to more comprehensively assess the clinical and 
      economic implications of adding avelumab to the treatment armamentarium of 2L 
      mUC.
CI  - (c) 2019 Kongnakorn et al.
FAU - Kongnakorn, Thitima
AU  - Kongnakorn T
AD  - Evidence Synthesis, Modeling and Communication, Evidera, London, UK.
FAU - Bharmal, Murtuza
AU  - Bharmal M
AD  - Global Evidence and Value Development, EMD Serono, Inc. (A business of Merck 
      KGaA, Darmstadt, Germany), Rockland, MA, USA.
FAU - Kearney, Mairead
AU  - Kearney M
AD  - Global Evidence and Value Development, Merck KGaA, Darmstadt, Germany.
FAU - Phatak, Hemant
AU  - Phatak H
AD  - US Health Economics and Outcomes Research, EMD Serono, Inc. (A business of Merck 
      KGaA, Darmstadt, Germany), Rockland, MA, USA.
FAU - Benedict, Agnes
AU  - Benedict A
AD  - Evidence Synthesis, Modeling and Communication, Evidera, Budapest, Hungary.
FAU - Bhanegaonkar, Abhijeet
AU  - Bhanegaonkar A
AD  - US Health Economics and Outcomes Research, EMD Serono, Inc. (A business of Merck 
      KGaA, Darmstadt, Germany), Rockland, MA, USA.
FAU - Galsky, Matthew
AU  - Galsky M
AD  - Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, 
      USA.
LA  - eng
PT  - Journal Article
DEP - 20191108
PL  - New Zealand
TA  - Clinicoecon Outcomes Res
JT  - ClinicoEconomics and outcomes research : CEOR
JID - 101560564
PMC - PMC6850681
OTO - NOTNLM
OT  - budget impact model
OT  - chemotherapy
OT  - cost analysis
OT  - economic analysis
OT  - immuno-oncology
OT  - urothelial carcinoma
COIS- T. Kongnakorn and A. Benedict are employees of Evidera. T. Kongnakorn reports 
      grants from Merck Healthcare KGaA, Darmstadt, Germany, outside the submitted 
      work. M. Kearney is an employee of Merck Healthcare KGaA, Darmstadt, Germany. M. 
      Bharmal, A. Bhanegaonkar and H. Phatak are employees of EMD Serono, Rockland, MA 
      (a business of Merck KGaA). M. Galsky is an employee of Icahn School of Medicine 
      at Mount Sinai, New York, NY, and reports a consulting/advisory role with 
      Genentech, Bristol-Myers Squibb, Merck, AstraZeneca, EMD Serono, Pfizer, and 
      Astellas and received research funding from Merck, Pfizer, AstraZeneca, 
      Bristol-Myers Squibb, Roche/Genentech, and Seattle Genetics, outside the 
      submitted work. The authors report no other conflicts of interest in this work.
EDAT- 2019/12/07 06:00
MHDA- 2019/12/07 06:01
PMCR- 2019/11/08
CRDT- 2019/12/07 06:00
PHST- 2019/05/09 00:00 [received]
PHST- 2019/10/11 00:00 [accepted]
PHST- 2019/12/07 06:00 [entrez]
PHST- 2019/12/07 06:00 [pubmed]
PHST- 2019/12/07 06:01 [medline]
PHST- 2019/11/08 00:00 [pmc-release]
AID - 215069 [pii]
AID - 10.2147/CEOR.S215069 [doi]
PST - epublish
SO  - Clinicoecon Outcomes Res. 2019 Nov 8;11:659-672. doi: 10.2147/CEOR.S215069. 
      eCollection 2019.